LLIF Plus Posterior Decompression for Severe Lumbar Spinal Stenosis

Lumbar Spinal Stenosis Clinical Trial

Official title:

A Randomized, Controlled Trial of Lateral Lumbar Interbody Fusion Plus Posterior Decompression or Not for Severe Lumbar Spinal Stenosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04094220
• Other study ID #: 2019-161
• Status: Completed
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: December 30, 2022

Study information

• Verified date: December 2020
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Lateral lumbar interbody fusion (LLIF), as a minimally invasive technique, is an indirect decompression technique, and its decompression effect is not as thorough as traditional posterior decompression surgery. For certain patients with severe lumbar stenosis, additional posterior decompression is required. However, whether additional posterior decompression is necessary for these patients is unknown. Radiographic predictors of failed indirect decompression via LLIF is unknown. In current randomized, controlled trial , the investigators compare the clinical outcomes of patients with severe lumbar stenosis who received LLIF plus posterior decompression and those without posterior decompression.

Description:

The current randomized controlled trial consists of two groups. Patients included in the study are with Schizas's stenosis grades C. Patients in one group received transpsoas lateral lumbar interbody fusion. Patients in the other group received transpsoas lateral lumbar interbody fusion plus posterior decompression. Patients will be followed for one year. Clinical outcomes of the two groups will be compared. And radiographic predictors of failed indirect decompression via LLIF will be analyzed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

Inclusion Criteria:

• Male and female patients who are 50 - 80 years of age.

• Patients who present with symptomatic Grade I or II degenerative spondylolisthesis at one or two contiguous lumbar levels between L1 and L5 and who are surgical candidates for interbody lumbar fusion surgery; symptoms should include radiculopathy and/or neurogenic claudication with or without back pain.

• Patients who have been unresponsive to at least 6 months of conservative treatments or who exhibit progressive neurological symptoms in the face of conservative treatment.

• Patients who understand the conditions of enrollment and are willing to sign an informed consent to participate in the study.

Exclusion Criteria:

• Patients with lumbar pathologies requiring treatment at more than two levels.

• Patients who have had previous lumbar fusion surgery.

• Patients with congenital lumbar stenosis.

• Patients with radiographic confirmation of Grade IV facet joint disease or degeneration.

• Patients with noncontained or extruded herniated nucleus pulposus.

• Patients with active local or systemic infection.

• Patients with rheumatoid arthritis or other autoimmune disease.

• Patients who cannot undergo magnetic resonance imaging (MRI).

• Patients who are mentally incompetent.

• Patients with BMI over 30kg/m2 or less than 18 kg/m2.

Related Conditions & MeSH terms

• Constriction, Pathologic
• Lumbar Spinal Stenosis
• Lumbar Spine Degeneration
• Spinal Stenosis

Intervention

Procedure:
• Lateral lumbar interbody fusion
LLIF is an indirect decompression technique, and does not directly remove the disc or osteophyte protruding into the spinal canal. Its decompression effect is not as thorough as traditional posterior decompression surgery. Usually, posterior decompression is required for patients who have unsuccessful indirect decompression.

Locations

Country	Name	City	State
China	The Second Affiliated Hospital of Medical College Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Axial central canal area	The area of the spinal central canal with the most stenosis at the level of the intervertebral disc on MRI.	Preoperative,postoperative,12-month,24-month after surgery
Other	Midsagittal canal diameter	The canal diameter at the midsagittal slice on MRI.	Preoperative,postoperative,12-month,24-month after surgery
Other	anterior and posterior disc height	The disc height at the anterior and posterior rim of the intervertebral disc on X-ray.	Preoperative,postoperative, 6-month,12-month,24-month after surgery
Other	The height of the bilateral intervertebral foramen	The distance of minimum diameter between adjacent pedicles on CT.	Preoperative,postoperative, 6-month,12-month,24-month after surgery
Other	Disc angle	The angles of the lines parallel to the upper and lower endplates in the intervertebral space.	Preoperative,postoperative, 6-month,12-month,24-month after surgery
Primary	Oswestry Disability Index (ODI)	The ODI is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability	Preoperative, 3-month, 12-month,24-month after surgery
Secondary	Visual Analogue Scale (VAS)	The VAS is a self-report measure of the intensity of pain (score range 0 - 10 ). A higher score indicates greater pain intensity.	Preoperative, 3-month, 12-month,24-month after surgery
Secondary	Zurich Claudication Questionnaire(ZCQ)	The ZCQ is a disease-specific self-report outcome instrument commonly used in trials to measure treatment outcomes in patients with lumbar spinal stenosis.The result is expressed as a percentage of the maximum possible score (22.22% - 100%). The score increases with worsening disability.The The ZCQ consists of three subscales: symptom severity scale, physical function scale and patient's satisfaction with treatment scale.	Preoperative, 3-month, 12-month,24-month after surgery